NoBoVersum

EU MDR IVDR Clinical Evaluation

NoBoVersum is a Budapest medical technology training and consulting company. Alongside its education programmes, it offers tailored consulting for manufacturers, distributors, importers and regulatory professionals facing EU MDR and IVDR requirements. Engagements range from answers to defined compliance questions through complete strategies for medical device developers entering the market. Its services include device classification, technical documentation, clinical evaluation planning and post-market surveillance systems.

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Getting Started

EU MDR: Step-By-Step Guide To Becoming Compliant

Updated 9 months ago

Dr. Oliver Eidel

3:06

Free MDR Templates

Dr. Oliver Eidel

103 views · over 2 years ago

Recommendations for EU Notified Bodies for CE and MDR applications outside Germany

Anonymous · 1 comment

6 months ago

Our company is developing a medical device software and is seeking recommendations for Notified Bodies in the EU, outside of Germany, where we can apply for CE marking and MDR certification within thi

Accepted 2 answers

A few months ago, Kiwa Dare in The Netherlands still had capacity to accept or at least discuss new customers, and they handle medical device software